Market Pathways covers the people, challenges, and opportunities impacting the global medtech regulatory, reimbursement, and policy communities. We invite you to explore our coverage. Think Strategically.
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In this week’s Pathways Picks: Key takeaways from MDMA's annual meeting in DC, including the first post-Trump public appearance by the CDRH director and comments from a top CMS official on medtech coverage; CDRH FOIA staff returns, while industry educators never left; Switzerland pursues efforts to rely on US FDA; and more global medtech policy news.
In this week’s Pathways Picks: Key takeaways from MDMA's annual meeting in DC, including the first post-Trump public appearance by the CDRH director and comments from a top CMS official on medtech coverage; CDRH FOIA staff returns, while industry educators never left; Switzerland pursues efforts to rely on US FDA; and more global medtech policy news.
Two key points along EBR Systems’ development of its novel WiSE CRT leadless heart failure device happened to line up with two of the biggest challenges faced by FDA’s device center in its history—the COVID-19 pandemic and recent mass layoffs. In both cases, CEO John McCutcheon says reviewers showed tremendous flexibility and resolve, and the system ultimately earned PMA approval April 11. The experience makes McCutcheon optimistic about CDRH’s future, despite current pressures.